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NCT05169801
To Compare the Efficacy and Safety of BP102 vs. Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC
Phase 3 trial testing BP102, paclitaxel, carboplatin in Non-small Cell Lung Cancer(NSCLC) in 520 participants. Completed in 17 June 2021.
21 October 2019
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 520 |
| Start date | 25 January 2018 |
| Primary completion | 21 October 2019 |
| Estimated completion | 17 June 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- BP102, paclitaxel, carboplatin — full drug profile →
- Avastin®, paclitaxel, carboplatin — full drug profile →
Conditions studied
- Non-small Cell Lung Cancer(NSCLC) — all drugs for Non-small Cell Lung Cancer(NSCLC) →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Non-small Cell Lung Cancer(NSCLC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Trial watch: chemotherapy-induced immunogenic cell death in oncology.
Sprooten J, Laureano RS, Vanmeerbeek I, Govaerts J, et al · · 2023 · cited 59× · PMID 37284695 · DOI 10.1080/2162402x.2023.2219591 -
Monoclonal antibody biosimilars for cancer treatment.
Broer LN, Knapen DG, de Groot DA, Mol PGM, et al · · 2024 · cited 4× · PMID 38974466 · DOI 10.1016/j.isci.2024.110115 -
Biosimilar monoclonal antibodies for cancer treatment in adults.
Galvao TF, Livinalli A, Lopes LC, Zimmermann IR, et al · · 2024 · cited 2× · PMID 39607013 · DOI 10.1002/14651858.cd013539.pub2
Verify or expand the search:
- PubMed search for NCT05169801
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05169801 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 27 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05169801.
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